氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.501883621881321878681883251878891881150.13
215.541868301874201871250.23
单位质量响应值RSD%判断
12136.4512041.510.56数据可信
供试品溶液-24051301批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123151-2315119.64921.385.8119.6521.385.81
225559-2555921.69221.69
324891-2489121.12521.13
424934-2493421.16221.16
524922-2492221.15221.15
627677-2767723.49023.49
10min138322-3832232.52535.206.7332.7435.446.73
240934-4093434.74234.98
340743-4074334.57934.81
441274-4127435.03035.27
540816-4081634.64134.88
646737-4673739.66739.93
15min147467-4746740.28644.117.5240.8744.747.51
251895-5189544.04444.67
350580-5058042.92843.55
452651-5265144.68645.31
550174-5017442.58443.20
659071-5907150.13550.84
20min153592-5359245.48549.567.2246.5150.687.21
257748-5774849.01250.13
356703-5670348.12549.22
459145-5914550.19851.32
557024-5702448.39749.49
666137-6613756.13257.39
30min159602-5960250.58555.787.6852.1257.457.66
264465-6446554.71356.37
363660-6366054.03055.66
468003-6800357.71659.39
564163-6416354.45656.09
674465-7446563.20065.08
45min164387-6438754.64761.248.1756.7463.528.13
270276-7027659.64561.91
371133-7113360.37262.60
474284-7428463.04665.37
570598-7059859.91862.15
682232-8223269.79272.38
60min166802-6680256.69662.937.8759.4065.907.84
271277-7127760.49463.43
372884-7288461.85864.76
477144-7714465.47468.49
572843-7284361.82364.72
683921-8392171.22574.59
极限184147-8414771.41776.963.8074.7580.623.80
290745-9074577.01780.62
391114-9111477.33080.92
493013-9301378.94282.69
593979-9397979.76283.35
691038-9103877.26681.42
氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.501871941867991868101875351866101869900.20
215.541870121874591872360.17
单位质量响应值RSD%判断
12063.8712048.650.09数据可信
供试品溶液-24050801批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137672-3767232.05931.399.7632.0631.399.77
239749-3974933.82733.83
339084-3908433.26133.26
437549-3754931.95531.95
529791-2979125.35225.35
637472-3747231.88931.89
10min154583-5458346.45146.709.5646.8147.059.56
258464-5846449.75350.13
358425-5842549.72050.09
455205-5520546.98047.34
544731-4473138.06738.35
657844-5784449.22649.58
15min163764-6376454.26454.139.3355.1455.009.32
265130-6513055.42656.35
367941-6794157.81958.74
465428-6542855.68056.56
551917-5191744.18244.89
667431-6743157.38458.29
20min167943-6794357.82059.326.1459.3060.795.94
270326-7032659.84861.39
372005-7200561.27762.84
461920-6192052.69554.19
573047-7304762.16463.36
672998-7299862.12263.66
30min173372-7337262.44063.328.7364.5665.458.64
278003-7800366.38168.59
378497-7849766.80269.05
476378-7637864.99867.08
561763-6176352.56154.45
678414-7841466.73168.96
45min176831-7683165.38464.549.4668.2067.379.21
282047-8204769.82372.77
382116-8211669.88272.87
480184-8018468.23771.04
566908-6690856.93959.41
666925-6692556.95459.92
60min181202-8120269.10469.878.0472.6473.427.95
285026-8502672.35876.08
385147-8514772.46176.23
485043-8504372.37275.93
569196-6919658.88761.99
686988-8698874.02877.63
极限194709-9470980.59881.334.8184.9085.664.90
297852-9785283.27387.80
398403-9840383.74288.31
496354-9635481.99886.36
586805-8680573.87277.63
699317-9931784.52088.95
氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.501873111865491865321865421863741866620.20
215.541869351860721865040.33
单位质量响应值RSD%判断
12042.7112001.540.25数据可信
供试品溶液-24051301批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135109-3510929.96331.234.7429.9631.234.75
237327-3732731.85631.86
338424-3842432.79232.79
438609-3860932.95032.95
534790-3479029.69129.69
635321-3532130.14430.14
10min147680-4768040.69142.955.2841.0243.295.28
251103-5110343.61343.97
353561-5356145.71146.07
453069-5306945.29145.66
547520-4752040.55540.88
649007-4900741.82442.16
15min153894-5389445.99548.425.0446.7849.255.04
258048-5804849.54050.38
359730-5973050.97551.85
459933-5993351.14952.02
553721-5372145.84746.63
655095-5509547.02047.82
20min157009-5700948.65350.964.6749.9552.324.67
261430-6143052.42653.82
362071-6207152.97354.41
462864-6286453.65055.09
556285-5628548.03549.33
658612-5861250.02151.34
30min160776-6077651.86853.824.5853.7055.754.59
265131-6513155.58557.56
365232-6523255.67157.70
466209-6620956.50558.54
559016-5901650.36652.19
662028-6202852.93654.81
45min163917-6391754.54955.774.5656.9658.304.54
268595-6859558.54161.13
366643-6664356.87559.52
467743-6774357.81460.48
560458-6045851.59753.98
664764-6476455.27157.74
60min165909-6590956.24956.925.2359.2760.065.16
271217-7121760.77964.02
367138-6713857.29860.58
468745-6874558.66961.97
560756-6075651.85154.81
666392-6639256.66159.74
极限1102464-10246487.44685.942.2991.0989.722.29
2104115-10411588.85592.77
3100486-10048685.75889.67
499769-9976985.14689.10
597533-9753383.23786.77
699805-9980585.17688.89
氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.501848521847851859361848131847961850360.28
215.541851461848121849790.13
单位质量响应值RSD%判断
11937.8111903.410.21数据可信
供试品溶液-24062101批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134071-3407129.32530.026.8629.3230.026.86
238669-3866933.28233.28
334171-3417129.41129.41
436627-3662731.52531.52
533864-3386429.14729.15
631877-3187727.43627.44
10min143090-4309037.08740.628.7737.4140.958.74
254842-5484247.20247.57
347753-4775341.10141.43
447161-4716140.59140.94
546034-4603439.62139.95
644278-4427838.11038.41
15min147323-4732340.73147.3210.7541.4748.1010.69
263923-6392355.01855.91
355428-5542847.70748.49
458921-5892150.71351.51
553529-5352946.07246.84
650720-5072043.65544.38
20min150067-5006743.09250.3912.2544.2851.7012.16
269437-6943759.76461.27
358504-5850450.35451.67
463936-6393655.02956.39
556619-5661948.73250.01
652725-5272545.38046.59
30min151397-5139744.23753.5012.9245.9155.3712.81
274569-7456964.18166.35
361549-6154952.97554.85
467354-6735457.97159.95
560728-6072852.26854.09
657352-5735249.36351.08
45min153518-5351846.06356.0913.4848.2258.5513.35
279123-7912368.10170.98
364762-6476255.74058.20
470198-7019860.41963.04
563310-6331054.49156.89
660065-6006551.69853.96
60min154128-5412846.58856.7513.4849.2659.8413.35
279592-7959268.50572.14
364914-6491455.87158.95
472108-7210862.06365.35
564045-6404555.12358.13
660823-6082352.35055.19
极限194285-9428581.15182.933.4484.3486.643.74
2102726-10272688.41692.82
395786-9578682.44386.14
496131-9613182.74086.72
595820-9582082.47286.09
693337-9333780.33583.76
氨氯地平叶酸片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.501852761861121863341859571859821859320.22
215.541841591846771844180.20
单位质量响应值RSD%判断
11995.6111867.310.77数据可信
供试品溶液-24061402批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131305-3130526.92028.825.2526.9228.825.25
235602-3560230.61530.62
332659-3265928.08528.08
435682-3568230.68430.68
532747-3274728.16028.16
633079-3307928.44628.45
10min143185-4318537.13639.244.8737.4439.564.88
248515-4851541.72042.06
344598-4459838.35138.66
448313-4831341.54641.89
544596-4459638.35038.66
644607-4460738.35938.68
15min154534-5453446.89644.254.8847.6145.014.78
248658-4865841.84342.65
350486-5048643.41544.15
454630-5463046.97847.78
550337-5033743.28744.03
650093-5009343.07743.82
20min151261-5126144.08146.784.9645.3148.024.91
257562-5756249.50050.77
353613-5361346.10447.32
457884-5788449.77751.10
552968-5296845.54946.77
653090-5309045.65446.87
30min154657-5465747.00249.494.2048.7251.264.18
260587-6058752.10153.92
357101-5710149.10350.84
460409-6040951.94853.83
556500-5650048.58650.31
656084-5608448.22949.96
45min156363-5636348.46951.163.4750.7153.473.43
262733-6273353.94656.34
360054-6005451.64353.92
459829-5982951.44953.90
559115-5911550.83553.10
658835-5883550.59452.86
60min158339-5833950.16852.873.4252.9555.753.41
263814-6381454.87657.87
361364-6136452.76955.62
463847-6384754.90457.93
560630-6063052.13854.97
660879-6087952.35255.18
极限191951-9195179.07281.261.3782.4184.731.39
295305-9530581.95685.56
395278-9527881.93385.37
494505-9450581.26884.90
594716-9471681.45084.86
695228-9522881.89085.30
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